Prevalence, factors associated and management of needle phobia among the general population in Saudi Arabia and Egypt.

OBJECTIVE: This study aims to assess the prevalence of needle phobia among Saudi and Egyptian adult populations. In addition, underlying causes and strategies that can be utilized to address needle fear were investigated. METHODS: A cross-sectional online survey study was conducted in Saudi Arabia and Egypt between 1 May and 30 June 2023. Participants aged 18 years and above and living in Saudi Arabia and Egypt were eligible to complete the survey. Participants were invited to participate in this study through social media platforms (Facebook, X, Snapchat, and Instagram). A convenience sampling technique was used to recruit the study participants. A 21-item questionnaire consisting of four sections including a Likert scale score was used to answer the research objectives. Numeric data were presented as mean ± SD. For categorical variables, percentages were used. Comparison between groups were made by Student's t-test or Mann Whitney test according to data distribution. Chi squared tests for categorical values were conducted. A binary logistic regression analysis was conducted to investigate factors associated with needle phobia. RESULTS: A total of 4065 participants were involved in this study (Saudi Arabia: 2628 and Egypt: 1437). Around one-third of the study participants (36.5%) confirmed that they have needle phobia. Most of the study participants (81.1%) reported that they have had needle phobia since they were under 18 years of age. Pain, general anxiety, and fear of making a mistake during the procedure were the most commonly reported contributors for fear of needles during or before a medical procedure. Around 15.8% of the study participants reported that they have tried to get rid of phobia from needles. Non-surgical alternatives (such as oral medications and patches) and using smaller/thinner needles were the most commonly reported interventions that reduced fear of needles. Binary logistic regression analysis identified that females, those who are aged (41-50 years), widowed, those with bachelor's degrees and higher education, and those unemployed were more likely to have needle phobia compared to others. CONCLUSION: Our study highlighted the high prevalence of needle fear within an adult population in Egypt and Saudi Arabia. Females, those who are aged (41-50 years), those widowed, those with higher education degrees, those unemployed, those working in the health sector and people with low income were more likely to have needle phobia compared to others.

Asthma medication adherence, control, and psychological symptoms: a cross-sectional study.

BACKGROUND: Nonadherence to therapies and psychological disorders are associated with poor asthma control. This study aims to assess the prevalence of anxiety and depressive symptoms, asthma control, and adherence to inhalers and to investigate whether there is an association of anxiety and depressive symptoms with adherence to inhalers and asthma control. METHODS: We measured anxiety and depressive symptoms using the Hospital Anxiety and Depression Scale in patients with asthma. Asthma Control Test and the 10-Item Test of Adherence to Inhalers Scale were used to assess levels of asthma control adherence to inhalers, respectively. Univariate and multivariate regression models assessed the associations of anxiety and depressive symptoms with adherence to inhalers and asthma control. RESULTS: A total of 287 patients completed the study, of whom 72% were female. The mean ± SD age and body mass index of our study population were 44 ± 13 years and 29 ± 7.2 kg/m2, respectively. Poor adherence to inhaler use was highly prevalent (49.8%; 95% CI: 43.8 to 55.7). The prevalence of anxiety, depression and poor asthma control was 27.2% (95% CI: 22.1 to 32.7), 20.9% (95% CI: 16.3 to 26.1), and 22.7% (95% CI: 17.9 to 27.9), respectively. We found a negative relationship between asthma control and anxiety, and depressive symptoms (adjusted ß: -0.25; 95% CI: -0.36 to -0.14; p < 0.001 and adjusted ß: -0.29; 95% CI: -0.40 to -0.18; p < 0.001, respectively). A negative relationship was also observed between adherence to inhalers and anxiety and depressive symptoms (adjusted ß: -0.34; 95% CI: -0.46 to -0.22; p < 0.001 and adjusted ß: -0.36; 95% CI: - 0.48 to - 0.24; p < 0.001, respectively). CONCLUSIONS: The high prevalence of uncontrolled asthma symptoms and poor adherence to inhalers and their impact on anxiety and depression levels among patients with asthma point to the need for early screening for psychological symptoms and recognition of nonadherence as part of asthma assessment and management plan in primary care in Saudi Arabia to avoid further worsening of asthma symptoms. Further studies are needed to explore the effectiveness of specific psychoeducational interventions and investigate the long-term impact of early psychological symptom detection on asthma outcomes.

Awareness and practice of airway pressure release ventilation mode in acute respiratory distress syndrome patients among nurses in Saudi Arabia.

BACKGROUND: This study aimed to assess the knowledge and current practice of using the airway pressure release ventilation (APRV) mode with acute respiratory distress syndrome (ARDS) patients and identify barriers to not using this mode of ventilation among nurses who work in critical areas in Saudi Arabia. METHODS: Between December 2022 and April 2023, a cross-sectional online survey was disseminated to nurses working in critical care areas in Saudi Arabia. The characteristics of the respondents were analyzed using descriptive statistics. Percentages and frequencies were used to report categorical variables. RESULTS: Overall, 1,002 nurses responded to the online survey, of whom 592 (59.1%) were female. Only 248 (24.7%) nurses had ever used APRV mode, whereas only 229 (22.8%) received training on APRV mode. Moreover, 602 (60.0%) nurses did not know whether APRV was utilized in their hospital. Additionally, 658 (65.6%) nurses did not know whether APRV mode was managed using a standard protocol. Prone positioning was the highest recommended intervention by 444 (43.8%) when a conventional MV failed to improve oxygenation in patients with ARDS. 323 (32.2%) respondents stated that the P-high should be set equal to the plateau pressure on a conventional ventilator, while 400 (39.9%) said that the P-low should match PEEP from a conventional ventilator. Almost half of the respondents (446, 44.5%) stated that the T-high should be set between 4 and 6 s, while 415 (41.4%) said that the T-low should be set at 0.4 to 0.8 s. Over half of the nurses (540, 53.9%) thought that the maximum allowed tidal volume during the release phase should be 4-6 ml/kg. Moreover, 475 (47.4%) believed that the maximum allowed P-high setting should be 35 cm H2O. One-third of the responders (329, 32.8%) stated that when weaning patients with ARDS while in APRV mode, the P-high should be reduced gradually to reach a target of 10 cm H2O. However, 444 (44.3%) thought that the T-high should be gradually increased to reach a target of 10 s. Half of the responders (556, 55.5%) felt that the criteria to switch the patient to continuous positive airway pressure (CPAP) were for the patient to have an FiO2 ≤ 0.4, P-high ≤ 10 cm H2O, and T-high ≥ 10 s. Lack of training was the most common barrier to not using APRV by 615 (61.4%). CONCLUSION: The majority of nurses who work in critical care units have not received sufficient training in APRV mode. A significant discrepancy was observed regarding the clinical application and management of APRV parameters. Inadequate training was the most frequently reported barrier to the use of APRV in patients with ARDS.

The utility of the necessity-concerns framework (NCF) in explaining adherence and parental beliefs about controller medication in Saudi Arabian children with asthma.

OBJECTIVE: This study aims to assess beliefs about asthma controller medications among parents of Saudi Arabian children with asthma and the association between these beliefs and medication adherence using the Necessity-Concerns Framework. METHODS: A cross-sectional survey was provided to parents of children with asthma when they brought their children to routine appointments at local public clinics between May 16 and July 10, 2018. Participants electronically filled out validated Arabic versions of the Medication Adherence Reported Scale (MARS) and Beliefs About Medications Questionnaire (BMQ). Descriptive statistics were used to characterize the study participants, while hierarchical linear regression analysis assessed associations between parental beliefs about controller medications and medication adherence. RESULTS: A total of 381 parents of children with asthma completed the study survey. The vast majority (89%) of study participants were non-adherent to their children's prescribed medications while only 11% were adherent. Additionally, our study revealed a significantly positive association between adherence and parents' beliefs in the necessity of the medication (p < .001), with concerns about the adverse effects of medication being negatively associated with parental adherence. A higher mean score for medication adherence was reported among the ambivalent groups compared to the accepting, indifferent, and skeptical groups. CONCLUSIONS: Medication adherence among parents of children with asthma was relatively low. In addition, necessity beliefs were significantly associated with parental adherence to controller medications for their children with asthma. Further studies are warranted to investigate potential factors contributing to poor parental adherence and develop tailored interventions that support parental medication adherence for their asthmatic children.

Trends in hospital admissions and prescribing due to chronic obstructive pulmonary disease and asthma in England and Wales between 1999 and 2020: an ecological study.

OBJECTIVE: To investigate the trends in hospital admissions and medication prescriptions related to asthma and chronic obstructive pulmonary disease (COPD) in England and Wales. METHODS: An ecological study was conducted between April 1999 and April 2020 using data extracted from the hospital episode statistics database in England and the patient episode database for Wales. The Office of National Statistics mid-year population estimates for 1999 through 2020 were collected, and medication prescription data for 2004-2020 were extracted from the prescription cost analysis database. RESULTS: The total annual number of COPD and asthma hospital admissions for various causes increased by 82.2%, from 210,525 in 1999 to 383,652 in 2020, representing a 59.1% increase in hospital admission rate (from 403.77 in 1999 to 642.42 per 100,000 persons in 2020, p < 0.05). Chronic obstructive pulmonary disease with acute lower respiratory infection accounted for 38.7% of hospital admissions. Around 34.7% of all hospital admissions involved patients aged 75 and older. Around 53.8% of all COPD and asthma hospital admissions were attributable to females. The annual number of prescriptions dispensed for COPD and asthma medications increased by 42.2%. CONCLUSIONS: Throughout the study period, hospital admissions due to chronic obstructive pulmonary disease and asthma, as well as medication prescriptions, increased dramatically among all age groups. Hospitalization rates were higher for women. Further observational and epidemiological research is required to identify the factors contributing to increased hospitalization rates.

The rate of ward to intensive care transfer and its predictors among hospitalized COPD patients, a retrospective study in a local tertiary center in Saudi Arabia.

OBJECTIVE: To investigate the prevalence of intensive care unit (ICU) admission and its predictors among hospitalized chronic obstructive pulmonary disease (COPD) patients. METHODS: An observational retrospective study was conducted. All patients with a confirmed diagnosis of COPD according to the GOLD guidelines between 28 and 2020 and 1 March 2023 at Al-Noor Specialist Hospital were included in this study. Patients were excluded if a preemptive diagnosis of COPD was made clinically without spirometry evidence of fixed airflow limitation. Descriptive results were presented as frequency (percentage) for categorical variables and mean (SD) for continuous variables and to estimate prevalence of ICU admission. Predictors of ICU admission among hospitalized COPD patients were determined using logistic regression analysis. A SPSS (Statistical Package for the Social Sciences) version 25 was used to perform all statistical analysis. RESULTS: A total of 705 patients with COPD were included in this study. The mean age was 65.4 (25.3) years. Around 12.4% of the hospitalized patients were admitted to the ICD. Logistic regression analysis identified that older age (OR; 1.92, (1.41-2.62)), smoking (OR; 1.60 (1.17-2.19)), and having specific comorbidities (Hypertension (OR; 1.98 (1.45-2.71)), Diabetes mellitus (OR; 1.42 (1.04-1.93)), GERD (OR; 2.81 (1.99-3.96)), Ischemic heart disease (OR; 3.22 (2.19-4.75)), Obstructive sleep apnea syndrome (OR; 2.14 (1.38-3.33)), stroke (OR; 4.51 (2.20-9.26))) were predictors of ICU admissions among patients with COPD. CONCLUSIONS: Our study found that a step-up approach to inpatient COPD management requires admission to the ICU in 12.4%, for which age, smoking status, cardiovascular, and stroke were important predictors. Further clinical research is needed to provide a validated model that can be incorporated into clinical practice to monitor this patient population during their admission and identify at-risk individuals for early transfer to higher acuity settings and intensive care units.

COVID-19 vaccination side effects among the child age group: a large cross-sectional online based survey in Saudi Arabia.

BACKGROUND: Multiple vaccines have been tested in clinical trials for their efficacy and safety. In Saudi Arabia, Pfizer-BioNTech or Moderna were approved for children, however, previous studies to report their safety profile are limited. This research aims to understand the side effect of children's vaccination against SARS-CoV-2 infection in Saudi Arabia. METHODS: This was an observational retrospective cross-sectional study was conducted using an online survey in Saudi Arabia from March to May 2022. The inclusion criteria were parents aged 18 years and above who live in Saudi Arabia and have vaccinated their children. The self-reported questionnaire was adopted from published studies to investigate the study objectives Descriptive statistics were used to describe patients' demographic characteristics, continuous data were reported as mean ± S.D., categorical data were reported as percentages (frequencies), and logistic regression was used to identify predictors of persistent post-COVID-19 symptoms. RESULTS: This study had a total of 4,069 participants. Only 41.9% of the participants reported that their child(ren) had been infected with the coronavirus. 2.00 was the median number of children (IQR: 1.00-4.00). More than half of the study participants (64.2%) reported that a family member had been infected with the coronavirus. Both parents received COVID-19 vaccination, according to most participants (88.7%). Most participants (70.5%) stated that all children who met the vaccination criteria had received the vaccine. Most participants (83.5%) said their child or children had two doses of their vaccine, and about half (50.4%) of those who received the vaccine reported experiencing side effects. In addition, the majority (78.9%) reported that the side effects appeared within one day of receiving the vaccine, and nearly two-thirds (65.7%) reported that the side effects lasted between one and three. A total of 11,831 side effects cases were documented. Pain at the injection site, hyperthermia, and fatigue were the most reported side effects, accounting for 15.3%, 14.1%, and 13.2%, respectively. CONCLUSION: It appears that the side effects of the COVID-19 vaccine for children are minor, tolerable, and like those described previously in clinical trials. Our data should encourage the public about the safety of receiving the COVID-19 vaccine for children.

Future Acceptability of Respiratory Virus Infection Control Interventions in General Population to Prevent Respiratory Infections.

Background and Objectives: In both pandemic and non-pandemic situations, nonpharmaceutical public health measures may offer easy, low-cost, and effective means of reducing the spread and impact of acute respiratory infections. It is unknown whether such measures would be acceptable to the Saudi community beyond the current pandemic. Materials and Methods: A validated survey was used to test community acceptance of the measures. Respondents were asked which infection control practices they planned to maintain and which they believed should be policies for the community as a whole after the COVID-19 pandemic has subsided. Results: The survey was completed by 2057 people (95% completion rate), 1486 (72%) of whom were female, 259 (12.5%) of whom were current smokers, and 72 (3.5%) of whom had chronic lung disease. The most prevalent age groups were 18−30 years (933; 45.4%) and 31−40 years (483; 23.5%), with 641 individuals over 40 years old. Of the responses, 93% indicated that they would continue washing their hands more often; 92% wanted both clinicians and patients to wear masks in hospitals; 86% would continue avoiding smoking in indoor and outdoor areas; 73% would continue wearing a face covering on public transportation; 70% indicated that they would continue wearing a face covering in indoor public places. Regarding the respiratory virus infection control measures, 85% (11/13) received significant support (≥70% acceptability level) for continuation as policies in the future. Wearing face coverings outdoors and social distancing outdoors received little support (45% and 66%, respectively). Of the respiratory virus infection control measures, 54% received less support from current smokers than non-smokers (acceptability level < 70%). People with chronic respiratory disease supported 77% of the measures being regarded as policies in the future. Conclusion: The Saudi community supports nonpharmacological respiratory infection control measures that reduce the likelihood of infection. Public health campaigns should target smokers to increase awareness of the importance of these measures in lowering infections. Based on the findings of this study, nonpharmacological treatments should be presented and included in future recommendations for both the public and patients diagnosed with chronic respiratory diseases.

Role of Sedation and Analgesia during Noninvasive Ventilation: Systematic Review of Recent Evidence and Recommendations.

Aim: This systematic review aimed to investigate the drugs used and their potential effect on noninvasive ventilation (NIV). Background: NIV is used increasingly in acute respiratory failure (ARF). Sedation and analgesia are potentially beneficial in NIV, but they can have a deleterious impact. Proper guidelines to specifically address this issue and the recommendations for or against it are scarce in the literature. In the most recent guidelines published in 2017 by the European Respiratory Society/American Thoracic Society (ERS/ATS) relating to NIV use in patients having ARF, the well-defined recommendation on the selective use of sedation and analgesia is missing. Nevertheless, some national guidelines suggested using sedation for agitation. Methods: Electronic databases (PubMed/Medline, Google Scholar, and Cochrane library) from January 1999 to December 2019 were searched systematically for research articles related to sedation and analgosedation in NIV. A brief review of the existing literature related to sedation and analgesia was also done. Review results: Sixteen articles (five randomized trials) were analyzed. Other trials, guidelines, and reviews published over the last two decades were also discussed. The present review analysis suggests dexmedetomidine as the emerging sedative agent of choice based on the most recent trials because of better efficacy with an improved and predictable cardiorespiratory profile. Conclusion: Current evidence suggests that sedation has a potentially beneficial role in patients at risk of NIV failure due to interface intolerance, anxiety, and pain. However, more randomized controlled trials are needed to comment on this issue and formulate strong evidence-based recommendations. How to cite this article: Karim HMR, Sarc I, Calandra C, Spadaro S, Mina B, Ciobanu LD, et al. Role of Sedation and Analgesia during Noninvasive Ventilation: Systematic Review of Recent Evidence and Recommendations. Indian J Crit Care Med 2022;26(8):938-948.

Hospital admission trends due to respiratory diseases in England and Wales between 1999 and 2019: an ecologic study.

BACKGROUND: Identifying trends of hospital admissions for respiratory diseases is crucial for public health and research to guide future clinical improvements for better outcomes. This study aims to define the trends of respiratory disease-related hospital admissions (RRHA) in England and Wales between 1999 and 2019. METHODS: An ecological study was conducted using hospital admission data taken from the Hospital Episode Statistics database in England and the Patient Episode Database for Wales. Hospital admissions data for respiratory diseases were extracted for the period between April 1999 and March 2019. The trend in hospital admissions was assessed using a Poisson model. RESULTS: Hospital admission rate increased by 104.7% [from 1535.05 (95% CI 1531.71-1538.38) in 1999 to 3142.83 (95% CI 3138.39-3147.26) in 2019 per 100,000 persons, trend test, p < 0.01]. The most common causes were influenza and pneumonia, chronic lower respiratory diseases, other acute lower respiratory infections, which accounted for 26.6%, 26.4%, and 14.9%, respectively. The age group 75 years and above accounted for 34.1% of the total number of hospital admissions. Males contributed to 50.5% of the total number of hospital admissions. Hospital admission rate in females increased by 119.8% [from 1442.18 (95% CI 1437.66-1446.70) in 1999 to 3169.38 (95% CI 3163.11-3175.64) in 2019 per 100,000 persons, trend test, p < 0.001]. Hospital admission rate increased by 92.9% in males [from 1633.25 (95% CI 1628.32-1638.17) in 1999 to 3149.78 (95% CI 3143.46-3156.09) in 2019 per 100,000 persons, trend test, p < 0.001]. CONCLUSION: During the study period, hospital admissions rate due to respiratory diseases increased sharply. The rates of hospital admissions were higher among males for the vast majority of respiratory diseases. Further observational studies are warranted to identify risk factors for these hospital admissions and to offer relevant interventions to mitigate the risk.

Thoracoscopy in prone position with two-lung ventilation compared to conventional thoracotomy during Ivor Lewis procedure: a multicenter case-control study.

BACKGROUND: Intraoperative management based on thoracoscopy, prone position and two-lung ventilation could decrease the rate of postoperative pulmonary complications after esophagectomy. The aim of this study was to compare this multifaceted approach (MIE-PP) and conventional thoracotomy for Ivor Lewis procedure after a systematic laparoscopic dissection. METHODS: Data from 137 consecutive patients undergoing Ivor Lewis procedures between 2010 and 2017 at two tertiary centers was analyzed retrospectively. The outcomes of patients who underwent MIE-PP (n = 58; surgeons group 1) were compared with those of patients undergoing conventional approach (n = 79; surgeons group 2). Our primary outcome was major postoperative pulmonary complications. Our main secondary outcomes were anastomotic leak, quality of resection and mortality. RESULTS: Female patients were more prevalent in the MIE-PP group (p = 0.002). Other patient characteristics, cTNM staging and neoadjuvant treatment rate were not different between groups. Major postoperative pulmonary complications were significantly lower in the MIE-PP group compared to Conventional group (24 vs. 44%; p = 0.014). Anastomotic leak occurred in 31 versus 18% in MIE-PP group and Conventional groups, respectively (p = 0.103). Complete resection rate (98 vs. 95%; p = 0.303) and mean number of harvested lymph nodes (16 (4-40) vs. 18 (3-37); p = 0.072) were similar between the two groups. Postoperative mortality rates were 0 versus 2% at day 30 (p = 0.508) and 0 versus 7.6% at day 90 (p = 0.038). CONCLUSION: Short-term outcomes of minimally invasive Ivor Lewis using thoracoscopy, prone position and two-lung ventilation are at least equivalent to the hybrid approach. Anastomotic leak after MIE-PP remains a major concern.

Nutritional supplementation during pulmonary rehabilitation in COPD: A systematic review.

Uptake of nutritional supplementation during pulmonary rehabilitation (PR) for people with chronic obstructive pulmonary disease (COPD) has been limited by an absence of rigorous evidence-based studies supporting use. The objective was to report and summarise the current evidence supporting the use of nutritional supplementation to improve outcomes during PR in stable COPD patients. A systematic search was conducted up to 7 August 2019 (registration number CRD42018089142). The preferred reporting items for systematic reviews and meta-analyses guidelines were used. Six databases were included: Medical Literature Analysis and Retrieval System Online or MEDLARS Online, Allied and Complementary Medicine Database, the Cochrane Database of Systematic Reviews, Excerpta Medica dataBASE, Cumulative Index of Nursing and Allied Health Literature and Web of Science. This systematic search generated 580 initial matches, of which 22 studies (917 COPD participants) met the pre-specified criteria and were included. Sixteen of 19 studies that used nutritional supplements in addition to PR did not show additional benefit compared to PR alone when measuring exercise capacity. Nutritional supplements significantly increased body weight in 7 of 11 studies. Body mass index increased significantly in two of six studies. Handgrip strength did not improve, while quadriceps muscle strength significantly improved in 3 of 11 studies. Four of eight studies showed a significant improvement in inspiratory muscle function. Only 2 of 14 studies demonstrated a significant improvement in quality of life with supplementation in addition to PR. There remains insufficient evidence on the effect of nutritional supplementation on improving outcomes during PR in patients with COPD due to heterogeneity in supplements, outcome measures and PR programmes. Therefore, controversy remains and further research is needed.

Pulmonary rehabilitation, physical activity and aortic stiffness in COPD.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) have elevated cardiovascular risk, and cardiovascular disease is a major cause of death in COPD. The current literature indicates that changes in cardiovascular risk during pulmonary rehabilitation (assessed using aortic stiffness) are heterogeneous suggesting that there may be sub-groups of patients who do and do not benefit. OBJECTIVES: To investigate the characteristics of COPD patients who do and do not experience aortic stiffness reduction during pulmonary rehabilitation, examine how changes relate to physical activity and exercise capacity, and assess whether changes in aortic stiffness are maintained at 6 weeks following rehabilitation. METHODS: We prospectively measured arterial stiffness (aortic pulse-wave velocity), exercise capacity (Incremental Shuttle Walk Test) and physical activity (daily step count) in 92 COPD patients who started a six week pulmonary rehabilitation programme, 54 of whom completed rehabilitation, and 29 of whom were re-assessed six weeks later. RESULTS: Whilst on average there was no influence of pulmonary rehabilitation on aortic stiffness (pre- vs. post pulse-wave velocity 11.3 vs. 11.1 m/s p = 0.34), 56% patients responded with a significant reduction in aortic stiffness. Change in aortic stiffness (absolute and/or percentage) during rehabilitation was associated with both increased physical activity (rho = - 0.30, p = 0.042) and change in exercise capacity (rho = - 0.32, p = 0.02), but in multivariable analysis most closely with physical activity. 92% of the responders who attended maintained this response six weeks later. CONCLUSION: Elevated aortic stiffness in COPD is potentially modifiable in a subgroup of patients during pulmonary rehabilitation and is associated with increased physical activity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03003208. Registered 26/12/ 2016.

Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial.

Importance: An intraoperative higher level of positive end-expiratory positive pressure (PEEP) with alveolar recruitment maneuvers improves respiratory function in obese patients undergoing surgery, but the effect on clinical outcomes is uncertain. Objective: To determine whether a higher level of PEEP with alveolar recruitment maneuvers decreases postoperative pulmonary complications in obese patients undergoing surgery compared with a lower level of PEEP. Design, Setting, and Participants: Randomized clinical trial of 2013 adults with body mass indices of 35 or greater and substantial risk for postoperative pulmonary complications who were undergoing noncardiac, nonneurological surgery under general anesthesia. The trial was conducted at 77 sites in 23 countries from July 2014-February 2018; final follow-up: May 2018. Interventions: Patients were randomized to the high level of PEEP group (n = 989), consisting of a PEEP level of 12 cm H2O with alveolar recruitment maneuvers (a stepwise increase of tidal volume and eventually PEEP) or to the low level of PEEP group (n = 987), consisting of a PEEP level of 4 cm H2O. All patients received volume-controlled ventilation with a tidal volume of 7 mL/kg of predicted body weight. Main Outcomes and Measures: The primary outcome was a composite of pulmonary complications within the first 5 postoperative days, including respiratory failure, acute respiratory distress syndrome, bronchospasm, new pulmonary infiltrates, pulmonary infection, aspiration pneumonitis, pleural effusion, atelectasis, cardiopulmonary edema, and pneumothorax. Among the 9 prespecified secondary outcomes, 3 were intraoperative complications, including hypoxemia (oxygen desaturation with Spo2 ≤92% for >1 minute). Results: Among 2013 adults who were randomized, 1976 (98.2%) completed the trial (mean age, 48.8 years; 1381 [69.9%] women; 1778 [90.1%] underwent abdominal operations). In the intention-to-treat analysis, the primary outcome occurred in 211 of 989 patients (21.3%) in the high level of PEEP group compared with 233 of 987 patients (23.6%) in the low level of PEEP group (difference, -2.3% [95% CI, -5.9% to 1.4%]; risk ratio, 0.93 [95% CI, 0.83 to 1.04]; P = .23). Among the 9 prespecified secondary outcomes, 6 were not significantly different between the high and low level of PEEP groups, and 3 were significantly different, including fewer patients with hypoxemia (5.0% in the high level of PEEP group vs 13.6% in the low level of PEEP group; difference, -8.6% [95% CI, -11.1% to 6.1%]; P < .001). Conclusions and Relevance: Among obese patients undergoing surgery under general anesthesia, an intraoperative mechanical ventilation strategy with a higher level of PEEP and alveolar recruitment maneuvers, compared with a strategy with a lower level of PEEP, did not reduce postoperative pulmonary complications. Trial Registration: ClinicalTrials.gov Identifier: NCT02148692.

Effect of preoxygenation using non-invasive ventilation before intubation on subsequent organ failures in hypoxaemic patients: a randomised clinical trial.

BACKGROUND: Previous data showed that non-invasive ventilation (NIV) applied for 3 min before tracheal intubation ensured better oxygenation compared with using a non-rebreather bag-valve-mask. We aimed to determine whether preoxygenation using NIV is effective in reducing the incidence of organ dysfunction in hypoxaemic, critically ill patients in intensive care. METHODS: A multicentre, randomised, open-label trial evaluating 100% FiO2 administered with NIV (99 patients) vs with face mask (102 patients) for 3 min before tracheal intubation. The primary endpoint was the maximal value of Sequential Organ Failure Assessment score within 7 days after intubation. RESULTS: The median (inter-quartile range) values of the maximal value of the Sequential Organ Failure Assessment score within 7 days post-intubation were not significantly different between the two randomised groups: nine (6-12) in the NIV group vs 10 (6-12) in the face mask group (P=0.65). In patients treated by NIV prior to the randomisation, there was a significant increase in the occurrence in adverse events in patients randomised to face mask [odds ratio=5.23 (1.61;16.99), P=0.0059]. CONCLUSIONS: This study failed to demonstrate any benefits of using NIV as a preoxygenation method to reduce organ dysfunction compared with usual preoxygenation in hypoxaemic, critically ill patients requiring tracheal intubation for invasive ventilation. NIV should not be discontinued for preoxygenation in the cases of patients treated by NIV before the decision to intubate. CLINICAL TRIAL REGISTRATION: NCT00472160.

Analgesia nociception index for the assessment of pain in critically ill patients: a diagnostic accuracy study.

BACKGROUND: Behavioural pain tools are used in Intensive Care Unit (ICU) patients unable to self-report their pain-intensity but need sustained efforts to educate and train the ICU team because of the subjective nature of these clinical tools. This study measured the validity and performance of an electrophysiological monitoring tool based on the spectral analysis of heart rate variability, the Analgesia Nociception Index (ANI) which varies from 0 (minimal parasympathetic tone, maximal stress-response and pain) to 100 (maximal parasympathetic tone, minimal stress-response and pain). METHODS: Mean-ANI (ANIm) and Instant-ANI (ANIi) were continuously recorded then compared with the Behavioral Pain Scale (BPS) before, during and after routine care procedures in critically-ill non-comatose patients. RESULTS: 969 assessments were performed in 110 patients. ANIi was the most discriminative pain tool. It was significantly correlated with BPS (r=-0.30; 95%CI -0.37 to -0.25; P<0.001). For an ANIi threshold of 42.5, the sensitivity, specificity, positive and negative predictive values were respectively 61.4%, 77.4%, 37.0%, and 90.4%. Compared with the BPS, ANIi had no significantly different ability to change during turning and tracheal-suctioning but changed significantly more during dressing change. ANIi increased independently with age, obesity and severity of illness, and controlled mechanical-ventilation, vasopressors use and analgesia. ANIi decreased independently when vigilance status and respiratory rate increased. ANIm demonstrated poor psychometric properties to detect pain. CONCLUSIONS: Despite low sensitivity/specificity, ANIi≥43 had a Negative-Predictive-Value of 90%. Hence ANIi may be of highest benefit for excluding significant pain. A randomized controlled trial should compare sedation-analgesia protocols based on ANIi to presently recommended behavioural-pain-tools.

Ten important articles on noninvasive ventilation in critically ill patients and insights for the future: A report of expert opinions.

BACKGROUND: Noninvasive ventilation is used worldwide in many settings. Its effectiveness has been proven for common clinical conditions in critical care such as cardiogenic pulmonary edema and chronic obstructive pulmonary disease exacerbations. Since the first pioneering studies of noninvasive ventilation in critical care in the late 1980s, thousands of studies and articles have been published on this topic. Interestingly, some aspects remain controversial (e.g. its use in de-novo hypoxemic respiratory failure, role of sedation, self-induced lung injury). Moreover, the role of NIV has recently been questioned and reconsidered in light of the recent reports of new techniques such as high-flow oxygen nasal therapy. METHODS: We conducted a survey among leading experts on NIV aiming to 1) identify a selection of 10 important articles on NIV in the critical care setting 2) summarize the reasons for the selection of each study 3) offer insights on the future for both clinical application and research on NIV. RESULTS: The experts selected articles over a span of 26 years, more clustered in the last 15 years. The most voted article studied the role of NIV in acute exacerbation chronic pulmonary disease. Concerning the future of clinical applications for and research on NIV, most of the experts forecast the development of innovative new interfaces more adaptable to patients characteristics, the need for good well-designed large randomized controlled trials of NIV in acute "de novo" hypoxemic respiratory failure (including its comparison with high-flow oxygen nasal therapy) and the development of software-based NIV settings to enhance patient-ventilator synchrony. CONCLUSIONS: The selection made by the experts suggests that some applications of NIV in critical care are supported by solid data (e.g. COPD exacerbation) while others are still waiting for confirmation. Moreover, the identified insights for the future would lead to improved clinical effectiveness, new comparisons and evaluation of its role in still "lack of full evidence" clinical settings.

Tacrolimus and the risk of solid cancers after liver transplant: a dose effect relationship.

Although increased rates of solid organ cancers have been reported following liver transplantation (LT), the impact of quantitative exposure to calcineurin inhibitors (CNI) remains unclear. We have therefore probed the relationship between the development of solid organ cancers following LT and the level of CNI exposure. This prospective single-center study was conducted between 1995 and 2008 and is based on 247 tacrolimus-treated liver transplant recipients who survived at least 1 year following surgery. The incidence of cancer was recorded, and the mean blood concentration of tacrolimus (TC) was determined at 1 and 3 years following LT. The study results indicate that 43 (17.4%) patients developed de novo solid cancers. Mean TC during the first year after LT was significantly higher in patients who developed solid organ tumors (10.3 ± 2.1 vs. 7.9 ± 1.9 ng/mL, p < 0.0001). Independent risks factors in multivariate analysis were tobacco consumption before LT (OR = 5.42; 95% CI [1.93-15.2], p = 0.0014) and mean annual TC during the first year after LT (p < 0.0001; OR = 2.01; 95% CI [1.57-2.59], p < 0.0001). Similar effects were observed in 216 patients who received tacrolimus continuously for ≥3 years. It appears therefore that CNI should be used with caution after LT, and that new immunosuppressive therapies could deliver significant clinical benefits in this regard.

Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units.

BACKGROUND: Intubation procedure in obese patients is a challenging issue both in the intensive care unit (ICU) and in the operating theatre (OT). The objectives of the study were (i) to compare the incidence of difficult intubation and (ii) its related complications in obese patients admitted to ICU and OT. METHODS: We conducted a multicentre prospective observational cohort study in ICU and OT in obese (BMI≥30 kg m(-2)) patients. The primary endpoint was the incidence of difficult intubation. Secondary endpoints were the risk factors for difficult intubation, the use of difficult airway management techniques, and severe life-threatening complications related to intubation (death, cardiac arrest, severe hypoxaemia, severe cardiovascular collapse). RESULTS: In cohorts of 1400 and 11 035 consecutive patients intubated in ICU and in the OT, 282 (20%) and 2103 (19%) were obese. In obese patients, the incidence of difficult intubation was twice more frequent in ICU than in the OT (16.3% vs 8.2%, P<0.01). In both cohorts, risk factors for difficult intubation were Mallampati score III/IV, obstructive sleep apnoea syndrome, and reduced mobility of cervical spine, while limited mouth opening, severe hypoxaemia, and coma appeared only in ICU. Specific difficult airway management techniques were used in 66 (36%) cases of difficult intubation in obese patients in the OT and in 10 (22%) cases in ICU (P=0.04). Severe life-threatening complications were significantly more frequent in ICU than in the OT (41.1% vs 1.9%, relative risk 21.6, 95% confidence interval 15.4-30.3, P<0.01). CONCLUSIONS: In obese patients, the incidence of difficult intubation was twice more frequent in ICU than in the OT and severe life-threatening complications related to intubation occurred 20-fold more often in ICU. CLINICAL TRIAL REGISTRATION: Current controlled trials. Identifier: NCT01532063.

Evaluation of pulse pressure variation validity criteria in critically ill patients: a prospective observational multicentre point-prevalence study.

BACKGROUND: Respiratory variation in pulse pressure (ΔPP) is commonly used to predict the fluid responsiveness of critically ill patients. However, some researchers have demonstrated that this measurement has several limitations. The present study was designed to evaluate the proportion of patients satisfying criteria for valid application of ΔPP at a given time-point. METHODS: A 1 day, prospective, observational, point-prevalence study was performed in 26 French intensive care units (ICUs). All patients hospitalized in the ICUs on the day of the study were included. The ΔPP validity criteria were recorded prospectively and defined as follows: (i) mechanical ventilation in the absence of spontaneous respiration; (ii) regular cardiac rhythm; (iii) tidal volume ≥8 ml kg(-1) of ideal body weight; (iv) a heart rate/respiratory rate ratio >3.6; (v) total respiratory system compliance ≥30 ml cm H2O(-1); and (vi) tricuspid annular peak systolic velocity ≥0.15 m s(-1). RESULTS: The study included 311 patients with a Simplified Acute Physiology Score II of 41 (39-43). Overall, only six (2%) patients satisfied all validity criteria. Of the 170 patients with an arterial line in place, only five (3%) satisfied the validity criteria. During the 24 h preceding the study time-point, fluid responsiveness was assessed for 79 patients. ΔPP had been used to assess fluid responsiveness in 15 of these cases (19%). CONCLUSIONS: A very low percentage of patients satisfied all criteria for valid use of ΔPP in the evaluation of fluid responsiveness. Physicians must consider limitations to the validity of ΔPP before using this variable.